U.S. patent application number 16/785372 was filed with the patent office on 2021-08-12 for antimicrobial coating extending performance of needleless connector.
The applicant listed for this patent is CareFusion 303, Inc.. Invention is credited to Tomas Frausto, George Mansour, Todd Oda, Archana Nagaraja Rao, Ali Saleh, Siddarth K. Shevgoor.
Application Number | 20210244934 16/785372 |
Document ID | / |
Family ID | 1000004655732 |
Filed Date | 2021-08-12 |
United States Patent
Application |
20210244934 |
Kind Code |
A1 |
Rao; Archana Nagaraja ; et
al. |
August 12, 2021 |
ANTIMICROBIAL COATING EXTENDING PERFORMANCE OF NEEDLELESS
CONNECTOR
Abstract
A needleless access connector having an access port and a
sustained release antimicrobial coating only on a top surface of
the access port is disclosed. The top surface of the access port
can be defined by a top surface of a proximal end of a housing and
a top surface of a head portion of a compressible valve disposed
within an internal cavity of the housing. In certain embodiments of
the present disclosure, the sustained release antimicrobial coating
is on: (i) the top surface the proximal end of the housing, or (ii)
the top surface of the head portion of the compressible valve, or
(iii) the sustained release antimicrobial coating is only on both
the top surface the proximal end of the housing and the top surface
of the head portion of the compressible valve.
Inventors: |
Rao; Archana Nagaraja; (San
Diego, CA) ; Shevgoor; Siddarth K.; (San Diego,
CA) ; Mansour; George; (San Diego, CA) ; Oda;
Todd; (San Diego, CA) ; Saleh; Ali; (San
Diego, CA) ; Frausto; Tomas; (San Diego, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
CareFusion 303, Inc. |
San Diego |
CA |
US |
|
|
Family ID: |
1000004655732 |
Appl. No.: |
16/785372 |
Filed: |
February 7, 2020 |
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61L 29/085 20130101;
A61L 2300/404 20130101; A61K 31/155 20130101; A61M 2205/0205
20130101; A61M 39/26 20130101; A61L 2300/206 20130101; A61M 39/10
20130101; A61L 29/16 20130101 |
International
Class: |
A61M 39/26 20060101
A61M039/26; A61M 39/10 20060101 A61M039/10; A61L 29/08 20060101
A61L029/08; A61L 29/16 20060101 A61L029/16; A61K 31/155 20060101
A61K031/155 |
Claims
1. A needleless access connector having an access port and a
sustained release antimicrobial coating only on a top surface of
the access port; wherein the top surface of the access port is
defined by a top surface of a proximal end of a housing and a top
surface of a head portion of a compressible valve reciprocally
disposed within an internal cavity of the housing.
2. The needleless access connector of claim 1, wherein the
sustained release antimicrobial coating is only on the top surface
the proximal end of the housing.
3. The needleless access connector of claim 1, wherein the
sustained release antimicrobial coating is only on the top surface
of the head portion of the compressible valve.
4. The needleless access connector of claim 1, wherein the
sustained release antimicrobial coating is only on the top surface
the proximal end of the housing and only on the top surface of the
head portion of the compressible valve.
5. The needleless access connector of claim 1, wherein the housing
comprises a polycarbonate (PC), a polyurethane (PU), a polyvinyl
chloride (PVC), a styrene-butadiene rubber (SBR), a polyacrylic or
acrylate, or combinations thereof.
6. The needleless access connector of claim 1, wherein the top
surface of the head portion of the compressible valve comprises a
silicone elastomer.
7. The needleless access connector of claim 1, wherein the
sustained release antimicrobial coating comprises a biodegradeable
polymer, a mesh forming polymer, a temperature/pH sensitive polymer
or combinations thereof.
8. The needleless access connector of claim 1, wherein the
sustained release antimicrobial coating is prepared from a UV
curable formulation.
9. The needleless access connector of claim 8, wherein the UV
curable formulation includes a urethane acrylate curable
adhesive.
10. The needleless access connector of claim 1, wherein the
sustained release antimicrobial coating comprises a chlorhexidine
salt as an antimicrobial agent.
11. The needleless access connector of claim 10, wherein the
sustained release antimicrobial coating releases the antimicrobial
agent over a period of at least 14 days.
12. The needleless access connector of claim 6, wherein the top
surface of the head portion of the compressible valve was treated
to be hydrophilic prior to forming the sustained release
antimicrobial coating on the surface of the valve.
13. The needleless access connector of claim 12, wherein the top
surface of the head portion of the compressible valve was treated
with a plasma prior to forming the sustained release antimicrobial
coating on the surface of the valve.
14. The needleless access connector of claim 1, wherein the
sustained release antimicrobial coating is in the form of a cap on
the top surface of the head portion of the compressible valve.
15. A needleless access connector comprising a housing having a
proximal end defining an access port of the housing, a distal end
including a base defining an outlet port of the housing, and an
inner surface defining an internal cavity extending between the
access and outlet ports; a compressible valve disposed within the
internal cavity and configured to contact at least a portion of the
inner surface, the compressible valve comprising a head portion and
a compressible body portion extending distally from the head
portion, wherein the top surface of the proximal end of the housing
is coated with a sustained release antimicrobial coating.
16. The needleless access connector of claim 15, wherein the top
surface of the proximal end of the housing includes a chamfer and
the sustained release antimicrobial coating is deposited in the
chamfer.
17. The needleless access connector of claim 15, further comprising
the sustained release antimicrobial coating slightly below the top
surface on the inner surface of the internal cavity of the
housing.
18. The needleless access connector of claim 17, wherein only the
top surface and the on the inner surface of the housing is coated
with the sustained release antimicrobial coating.
19. The needleless access connector of claim 15, wherein the
sustained release antimicrobial coating comprises a chlorhexidine
salt as an antimicrobial agent
20. The needleless access connector of claim 15, wherein the
sustained release antimicrobial coating releases the antimicrobial
agent over a period of at least 14 days.
Description
TECHNICAL FIELD
[0001] The present disclosure generally relates to needleless
connectors, and, in particular, to needleless connectors having a
sustained release antimicrobial coating to extend the performance
life of such connectors.
BACKGROUND
[0002] Needleless access connectors (NAC) are widely used
throughout the medical industry to connect and disconnect sources
of medical fluid (e.g., a saline solution or a liquid medication)
intended to be infused to a patient. Such connectors are commonly
used with intravenous (IV) catheters connected through an
arrangement of flexible tubing and fittings, commonly referred to
as an "IV set", to a source of fluid, for example, an IV bag.
[0003] Bacteria and other microorganisms may gain entry into a
patient's vascular system from access hubs and ports/valves upon
connection to the NAC. Each access hub (or port/valve or
connection) is associated with some risk of transmitting a catheter
related bloodstream infection (CRBSI), which can be costly and
potentially lethal.
[0004] To decrease catheter-related bloodstream infection (CRBSI)
cases and to ensure connectors are used and maintained correctly,
standards of practice have been developed, which include
disinfecting and cleaning procedures. For example, the 2016
Infusion Nurses Standards (INS) guidelines recommend that
needleless connectors should be consistently and thoroughly
disinfected using alcohol, tincture of iodine or chlorhexidine
gluconate/alcohol combination prior to each access.
[0005] The disinfection of the needleless connector is ultimately
intended to aid in the reduction of bacteria that could be living
on the surface and possibly lead to a variety of catheter related
complicationsincluding the CRBSI events described before. Nurses
will typically utilize a 70% IPA alcohol pad to complete this
disinfection task by doing what is known as "scrubbing the hub."
However, compliance to this practice and its efficacy do not appear
rigorous. In addition, health care professionals tend to change NAC
connectors often, e.g., at least weekly, to reduce infection due to
potential build-up of bacteria. However, a continuing need exists
to reduce potential bacterial infection and to extend the service
life of needleless access connectors.
SUMMARY
[0006] Aspects of the subject technology relate to needleless
access connectors with antimicrobial coatings thereon and in
particular to needleless access connectors having access ports with
sustained release antimicrobial coatings on a top surface of the
access port.
[0007] A needleless access connector can comprise an access port
defined by a top surface of a proximal end of a housing and a top
surface of a head portion of a compressible valve reciprocally
disposed within an internal cavity of the housing. For example,
needleless access connector can include a housing having a proximal
end defining an access port of the housing, a distal end including
a base defining an outlet port of the housing, and an inner surface
defining an internal cavity extending between the access and outlet
ports; a compressible valve disposed within the internal cavity and
configured to contact at least a portion of the inner surface, the
compressible valve comprising a head portion and a compressible
body portion extending distally from the head portion. In certain
aspects of the present disclosure, the top surface of the proximal
end of the housing and/or a top surface of the head portion of the
valve are coated with a sustained release antimicrobial coating
and/or the sustained release antimicrobial coating is slightly
below the top surface on the inner surface of the internal cavity
of the housing. In other aspects of the present disclosure, the
sustained release antimicrobial coating is only on the top surface
the proximal end of the housing and/or only on the top surface of
the head portion of the compressible valve and/or only slightly
below the top surface on the inner surface of the internal cavity
of the housing
[0008] Embodiments include one or more of the following features
individually or combined. For example, the top surface of the
proximal end of the housing can include a chamfer and the sustained
release antimicrobial coating can be deposited in the chamfer. In
some embodiments, the housing can comprise a polycarbonate (PC), a
polyurethane (PU), a polyvinyl chloride (PVC), a styrene-butadiene
rubber (SBR), a polyacrylic or acrylate, or combinations thereof.
In other embodiments, the top surface of the head portion of the
compressible valve can comprise a silicone elastomer. In still
further embodiments, the sustained release antimicrobial coating
can include a biodegradeable polymer, a mesh forming polymer, a
temperature/pH sensitive polymer or combinations thereof; and in
other embodiments, the sustained release antimicrobial coating
comprises a chlorhexidine salt as an antimicrobial agent.
[0009] Additional advantages of the subject technology will become
readily apparent to those skilled in this art from the following
detailed description, wherein only certain aspects of the subject
technology are shown and described, simply by way of illustration.
As will be realized, the subject technology is capable of other and
different configurations, and its several details are capable of
modifications in various other respects, all without departing from
the subject technology. Accordingly, the drawings and description
are to be regarded as illustrative in nature, and not as
restrictive.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] The accompanying, drawings, which are included to provide
further understanding and are incorporated in and constitute a part
of this specification, illustrate disclosed embodiments and
together with the description serve to explain the principles of
the disclosed embodiments. In the drawings:
[0011] FIG. 1A illustrates a needleless access connector having an
access port in accordance with some embodiments of the present
disclosure.
[0012] FIG. 1B illustrates a perspective view of the needleless
access connector of FIG. 1A.
[0013] FIG. 2 illustrates an access port a needleless access
connector in accordance with some embodiments of the present
disclosure.
DETAILED DESCRIPTION
[0014] The detailed description set forth below describes various
configurations of the subject technology and is not intended to
represent the only configurations in which the subject technology
may be practiced. The detailed description includes specific
details for the purpose of providing a thorough understanding of
the subject technology. Accordingly, dimensions are provided in
regard to certain aspects as non-limiting examples. However, it
will be apparent to those skilled in the art that the subject
technology may be practiced without these specific details. In some
instances, well-known structures and components are shown in block
diagram form in order to avoid obscuring the concepts of the
subject technology.
[0015] It is to be understood that the present disclosure includes
examples of the subject technology and does not limit the scope of
the appended claims. Various aspects of the subject technology will
now be disclosed according to particular but non-limiting examples.
Various embodiments described in the present disclosure may be
carried out in different ways and variations, and in accordance
with a desired application or implementation.
[0016] Aspects of the subject technology relate to needleless
access connectors (NAC) having access ports with a sustained
release antimicrobial coating on a top surface of the access port.
The top surface of an access port of a NAC can be defined by: (i) a
top surface of a proximal end of a housing and can extend into an
inner surface of an internal cavity; and (ii) a top surface of a
head portion of a compressible valve reciprocally disposed within
an internal cavity of the housing. In certain embodiments of the
present disclosure, the sustained release antimicrobial coating is
on: (i) the top surface the proximal end of the housing and
extended slightly below the access port, or (ii) the top surface of
the head portion of the compressible valve, or (iii) the sustained
release antimicrobial coating is only on both the top surface the
proximal end of the housing and the top surface of the head portion
of the compressible valve.
[0017] Coating only a top surface of an access port of an NAC
advantageously reduces the amount of antibiotic available with flow
of medical fluid through the connector and thus reduces the
antibiotic load on a patient using an NAC having only a top surface
with an antimicrobial coating. Reducing antibiotic load is
particularly advantageous when more than one NAC is used to deliver
fluids to a patient. In addition, coating the top surface of the
access port of an NAC with a sustained release antimicrobial
coating advantageously can extend the service life of the NAC
thereby reducing the need for frequent replacements of the NAC over
a given period of time.
[0018] Referring to FIG. 1A, a perspective view of a needleless
access connector having an access port is shown. FIG. 1B is a
perspective view of a partial cutaway of the needleless access
connector. As depicted in FIG. 1A and FIG. 1B, needleless access
connector 100 includes housing 102 which has proximal end 104 and a
distal end 106 defining outlet port 108 of housing 102. As referred
to herein, proximally refers to an orientation toward top port
surface 114 of the housing 102, and distally refers to an
orientation toward the base portion 106 or bottom of the housing
102, opposite the top port surface 114.
[0019] Housing 102 includes an inner surface 130 defining an
internal cavity 133 which extends at least partially between the
proximal and distal ends 104 and 106, respectively. Needleless
access connector 100 also includes compressible valve 200 disposed
within internal cavity 133 of housing 102. Compressible valve 200
includes head portion 220 and compressible body portion 230
extending distally from the head portion 220. For this example,
compressible valve is shown with a notched configuration in the
head portion and ribbed configuration in the body portion but
neither notches nor ribs are needed to practice the various aspects
of the present disclosure.
[0020] As further depicted in FIGS. 1A and 1B and also in FIG. 2,
access port 112 is defined by top surface 114 of proximal end 104
of housing 102 and top surface 204 of head portion 220 of
compressible valve 200. In certain embodiments, top surface 114 of
proximal end 104 of housing 102 can include a chamfer 116 which
contacts head portion 220 of compressible valve 200 when the valve
is in a closed state. Top surface 114 of proximal end 104 of
housing 102 and top surface 204 of head portion 220 of compressible
valve 200 can include a certain amount of a sustained release
antimicrobial coating. Applying an antimicrobial formulation to
coat the chamfer or crevice on a top surface of an access port of
an NAC can help control a predetermined volume of the coating on
the top surface and thus a predetermined amount of the
antimicrobial agent available at the access port. A predetermined
depth of a chamfer or crevice helps to consistently apply an amount
of antimicrobial coating to the access port in producing NAC and
thus to have a consistent and predictable release rate in
manufactured NACs.
[0021] Head portion of compressible valve forms a seal at or around
top surface 114 of proximal end 104 of housing 102 thereby
preventing ingress of materials. An additional advantage of
including chamfer 116 with a sustained release antimicrobial
coating at top surface 114 is to protect any potential vacant areas
or areas not in sufficient contact between valve head 220 and inner
surface 130 of internal cavity 133 when the valve is in the closed
position. Should bacteria locate in such areas, the coating on the
sustained release antimicrobial coating on the chamfer could
eradicate such bacteria thus protecting the interface between the
valve and the inner surface 130 of internal cavity 133 at and
around the valve head
[0022] In operation, compressible valve 200 of the needleless
connector can compress and collapse when an axial force is applied
to the top surface 204 of the compressible valve 200 and the valve
can expand and realign when the axial force is removed. Hence, when
an axial force (F) is applied to top surface 204 of the valve, the
valve (200) compress within internal cavity 133 of housing 102
allowing a fluid path from access port 112 to outlet port 108.
[0023] Access port 112 can include engagement features 140 for
coupling to another device (e.g., a fluid transfer assembly). For
example, engagement features 140 may include cooperating mechanical
elements, such as internal or external surface threads, detents,
bayonet-type locking elements, etc., as well as other surface
configurations, such as a tapered Luer surface for frictional
engagement. In some embodiments, the inlet port 112 may define a
female luer fitting with luer lock threading 140. In some
embodiments, the outlet port 108 may include engagement features
for coupling to another device or coupling to interconnect tubing.
For example, the outlet port 108 may comprise a male luer-taper
fitting and luer lock threading (not shown) for medical device
implement interconnection. However, engagement features of the
outlet port 108 may include other cooperating mechanical elements.
In operation, a fluid pathway may be established through needleless
connector from the access port 112 to the outlet port 108, for
example.
[0024] An additional advantage of including a sustained release
antimicrobial coating slightly below top surface 114 on inner
surface 130 of internal cavity 133 is that such a coating can
further protect ingress of active bacteria into the NAC. It is
preferable that any antimicrobial coating on inner surface 130 of
internal cavity 133 extend no further than the internal tapered
luer section and preferably out of a fluid path when the NAC is
connected with another implement. In certain aspects, a sustained
release antimicrobial coating is no more than about 4 mm, such as
less than about 3 mm, about 2 mm or about 1 mm below top surface
114 on inner surface 130 of internal cavity 133.
[0025] Housing 102, including top surface 114, can comprise one or
more rigid polymeric materials such as a polycarbonate (PC), a
polyurethane (PU), a polyvinyl chloride (PVC), a styrene-butadiene
rubber (SBR), a polyacrylic or acrylate, or combinations thereof.
Valve 200, including hear portion 220 and top surface 204, can
comprise an elastic, inert material, such as a silicone elastomer,
so that it is collapsible within the housing 102 and resists
adversely interacting with medicinal fluids.
[0026] While current designs for NAC are robust to resist bacterial
ingress, the access port is of particular concern since it is
typically exposed to the environment when not connected to a
medical implement. However, with a sustained release antimicrobial
coating on a top surface of the access port, bacterial formation or
build-up can be minimized or eliminated and these conditions can be
maintained for one or more weeks of use. Hence in an aspect of the
present disclosure, applying a sustained release antimicrobial
coating onto only a top surface of an access port of a NAC.
[0027] Useful sustained release antimicrobial coatings on surfaces
of access ports include those that are watersorable, flexible and
durable. Such coatings can be formed from formulations that include
one or more antimicrobial agents with one or more polymers.
Alternatively, or in combination with one or more antimicrobial
agents and polymers, the formulation can include polymer forming
components, e.g. UV curable monomers and/or oligomers. The
polymeric component of a formed antimicrobial coating are such that
they can release the antimicrobial agent over time, e.g., over a
period of at least 7 days, 14 days, 21 days, etc. The molecular
weight of the polymer of the formed coating can be adjusted to
control the release rate of the antimicrobial agent.
[0028] Useful polymers that can be included in formulations for
preparing antimicrobial coatings of the present disclosure include,
for example, biodegradeable polymers such as
poly(lactic-co-glycolic acid) (PLGA), polycaprolactone (PCL),
polyglycolide (PGL), polylactic acid (PLA), poly-3-hydroxybutyrate
(PBH), polysaccharides, polyethylene glycol (PEG),
polyethyleneoxide (PEO), mesh forming polymers such as cellulose
acetate, temperature/pH sensitive polymers such as hyaluronic acid,
poly(N-isopropylacrylamide) (NIPPam) etc. or co-polymers thereof
and/or combinations thereof.
[0029] Useful polymer forming components that can be included in
formulations for preparing sustained release antimicrobial coatings
of the present disclosure include, for example, UV curable
adhesives such as urethane acrylate curable adhesives or moisture
or temperature curable adhesive components such as cyanoacrylates.
UV curable formulation can include a combination of a urethane or a
polyester-type oligomer with acrylate-type functional groups,
acrylate-type monomers, as polymer forming components with an
antimicrobial agent and optional photoinitiators, rheological
modifiers, etc. Moisture or temperature curable adhesive components
can include a combination of a cyanoacrylate and an antimicrobial
agents, with optional activators, rheological modifiers, etc. The
antimicrobial agents are preferably uniformly and distributed
throughout the whole coating matrix
[0030] A wide variety of UV curable oligomers can be used with
formulations of the present disclosure. For example, the oligomers
can be acrylated aliphatic urethanes, acrylated aromatic urethanes,
acrylated polyesters, unsaturated polyesters, acrylated polyethers,
acrylated acrylics, and the like, or combinations of the above. The
acrylated functional group can be mono-functional, di-functional,
tri-functional, tetra-functional, penta-functional, or
hexa-functional.
[0031] As with the oligomers, a wide range of monomers can be used
with formulations of the present disclosure Such monomers include,
for example, 2-ethyl hexyl acrylate, isooctyl acrylate,
isobornylacrylate, 1,6-hexanediol diacrylate, diethylene glycol
diacrylate, triethylene glycol diacrylate, pentaerythritol tetra
acrylate, penta erythritol tri acrylate, dimethoxy phenyl
acetophenone hexyl methyl acrylate, 1,6 hexanidiol methacrylate,
and the like, or combinations thereof.
[0032] To facilitate UV-curing, UV curable formulations can include
an adequate and compatible photoinitiator. Such photoinitiators can
be: 1) single molecule cleavage type, such as benzoin ethers,
acetophenones, benzoyl oximes, and acyl phosphine oxide, and 2)
hydrogen abstraction type, such as Michler's ketone, thioxanthene,
anthroguionone, benzophenone, methyl diethanol amine,
2-N-butoxyethyl-4-(dimethylamino) benzoate, and the like, or
combinations thereof. The UV curable formulation can be rapidly
cured with ultraviolet light, e.g., curing can be completed in
seconds or minutes depending on the formulation and curing
conditions. The sustained release coatings of the present
disclosure are generally efficacious within minutes.
[0033] Useful antimicrobial agents that can be included in
formulations for preparing sustained release antimicrobial coatings
of the present disclosure include, for example, aldehydes,
anilides, biguanides, silver element or its compounds, bis-phenols,
and quaternary ammonium compounds and the like or combinations
thereof. In particular, suitable antimicrobial agents that can be
included in formulations for preparing sustained release coatings
of the present disclosure include, for example, a triclosan, a
chlorhexidine salt such as chlorhexidine gluconate (CHG),
chlorhexidine acetate (CHA), a chlorhexidine phosphanilate, a
silver salt, a chlorhexidine/silver sulfadiazine. The antimicrobial
agent can be included in a formulation the present disclosure in
the amount of from about 0.5 to about 50 parts by weight in
compared to 100 parts by weight of the formulation used to form the
coating, e.g., in the amount of from about 0.5 to about 30 parts by
weight of the formulation, such as from about 1 to about 20 parts
by weight.
[0034] Some particular formulations that can be applied include,
for example, a urethane acrylate adhesive with 8% CHA which can be
applied to a top of a housing of an NAC followed by curing the
formulation to form a sustained release antimicrobial coating
thereon. A top surface of a valve for an NAC can be subjected to a
primer, such as a primer for a silicone valve available from
companies such as Henkel and Loctite, followed by applying a
formulation including cyanoacrylate with 8% CHA and curing to form
a sustained release antimicrobial coating on the valve. A silicone
valve can be made more hydrophilic/wettable by plasma treatment or
the valve can be etched so that an acrylate urethane adhesive
formulation can be coated onto the top of the silicone valve.
[0035] Formulations for preparing sustained release coatings of the
present disclosure can be prepared by mixing an antibacterial agent
with a polymer, with or without solvent, to form a slurry or
solution. Alternatively to mixing the antibacterial agent with a
polymer, or in combination thereof, the antibacterial agent can be
mixed with polymer forming components to prepare a formulation for
preparing sustained release coatings. The formulation can then be
applied to top surfaces by spray coating, dip coating, and/or
wiping the formulation onto the surface. For example, a curable
formulation for preparing a sustained release antimicrobial coating
according to certain aspects of the present disclosure can be
prepared by combining polymer forming components with about 8 wt %
of an antimicrobial agent, e.g., fine powder of CHA (CHA can be
ground to a small mesh/pore size so that it can mix to form an
uniform distribution of the CHA in the formulation), to make a
slurry. The slurry can then be applied to top surfaces.
[0036] As described above, an access port of an NAC includes a top
surface of a compressible valve. Such valves are typically made
from inert materials such as a silicone elastomer. However adhering
a sustained release antimicrobial coating on such materials is
challenging due to the relative inertness and flexibility needed
for valves. To better adhere a sustained release antimicrobial
coating on a top surface of a compressible valve, the surface can
be modified.
[0037] Hence in an aspect of the present disclosure, prior to
applying a sustained release antimicrobial coating on a surface of
a valve, e.g., on a top surface of a silicone elastomeric valve,
the surface of the valve is treated to made the surface more
hydrophilic than an untreated surface. Such treatments can include,
for example, treating with an alcohol such as isopropyl alcohol
(IPA). The surface can also be made more hydrophilic by treating
the surface of the valve with a plasma of oxygen, argon or both or
by a pulse plasma wherein you can grow one or more desired
monomer(s) on the surface sequentially to form a hydrophilic
surface. The surface can be modified by applying a primer to the
surface of the valve followed by applying an adhesive formulation.
Such primers can be obtained from companies such as Henkel and
Loctite.
[0038] Another way to facilitate adhere a sustained release
antimicrobial coating on a top surface of a compressible valve it
to modify the surface by creating a surface roughness for better
adhesion. Further, the surface can be subjected to an ionized
bombardment of the antimicrobial agent, e.g., CHA to modify the
surface. The top surface of a valve can also be capped with a
polymeric material having an antimicrobial agent to act as a
sustained release antimicrobial coating on the surface of the
valve.
[0039] It is understood that any specific order or hierarchy of
blocks in the methods of processes disclosed is an illustration of
example approaches. Based upon design or implementation
preferences, it is understood that the specific order or hierarchy
of blocks in the processes may be rearranged, or that all
illustrated blocks be performed. In some implementations, any of
the blocks may be performed simultaneously.
[0040] The present disclosure is provided to enable any person
skilled in the art to practice the various aspects described
herein. The disclosure provides various examples of the subject
technology, and the subject technology is not limited to these
examples. Various modifications to these aspects will be readily
apparent to those skilled in the art, and the generic principles
defined herein may be applied to other aspects.
[0041] A reference to an element in the singular is not intended to
mean "one and only one" unless specifically so stated, but rather
"one or more." Unless specifically stated otherwise, the term
"some" refers to one or more. Pronouns in the masculine (e.g., his)
include the feminine and neuter gender (e.g., her and its) and vice
versa. Headings and subheadings, if any, are used for convenience
only and do not limit the invention.
[0042] The word "exemplary" is used herein to mean "serving as an
example or illustration." Any aspect or design described herein as
"exemplary" is not necessarily to be construed as preferred or
advantageous over other aspects or designs. In one aspect, various
alternative configurations and operations described herein may be
considered to be at least equivalent.
[0043] As used herein, the phrase "at least one of" preceding a
series of items, with the term "or" to separate any of the items,
modifies the list as a whole, rather than each item of the list.
The phrase "at least one of" does not require selection of at least
one item; rather, the phrase allows a meaning that includes at
least one of any one of the items, and/or at least one of any
combination of the items, and/or at least one of each of the items.
By way of example, the phrase "at least one of A, B, or C" may
refer to: only A, only B, or only C; or any combination of A, B,
and C.
[0044] A phrase such as an "aspect" does not imply that such aspect
is essential to the subject technology or that such aspect applies
to all configurations of the subject technology. A disclosure
relating to an aspect may apply to all configurations, or one or
more configurations. An aspect may provide one or more examples. A
phrase such as an aspect may refer to one or more aspects and vice
versa. A phrase such as an "embodiment" does not imply that such
embodiment is essential to the subject technology or that such
embodiment applies to all configurations of the subject technology.
A disclosure relating to an embodiment may apply to all
embodiments, or one or more embodiments. An embodiment may provide
one or more examples. A phrase such an embodiment may refer to one
or more embodiments and vice versa. A phrase such as a
"configuration" does not imply that such configuration is essential
to the subject technology or that such configuration applies to all
configurations of the subject technology. A disclosure relating to
a configuration may apply to all configurations, or one or more
configurations. A configuration may provide one or more examples. A
phrase such a configuration may refer to one or more configurations
and vice versa.
[0045] In one aspect, unless otherwise stated, all measurements,
values, ratings, positions, magnitudes, sizes, and other
specifications that are set forth in this specification, including
in the claims that follow, are approximate, not exact. In one
aspect, they are intended to have a reasonable range that is
consistent with the functions to which they relate and with what is
customary in the art to which they pertain.
[0046] It is understood that the specific order or hierarchy of
steps, operations or processes disclosed is an illustration of
exemplary approaches. Based upon design preferences, it is
understood that the specific order or hierarchy of steps,
operations or processes may be rearranged. Some of the steps,
operations or processes may be performed simultaneously. Some or
all of the steps, operations, or processes may be performed
automatically, without the intervention of a user. The accompanying
method claims, if any, present elements of the various steps,
operations or processes in a sample order, and are not meant to be
limited to the specific order or hierarchy presented.
[0047] All structural and functional equivalents to the elements of
the various aspects described throughout this disclosure that are
known or later come to be known to those of ordinary skill in the
art are expressly incorporated herein by reference and are intended
to be encompassed by the claims. Moreover, nothing disclosed herein
is intended to be dedicated to the public regardless of whether
such disclosure is explicitly recited in the claims. No claim
element is to be construed under the provisions of 35 U.S.C. .sctn.
112 (f) unless the element is expressly recited using the phrase
"means for" or, in the case of a method claim, the element is
recited using the phrase "step for." Furthermore, to the extent
that the term "include," "have," or the like is used, such term is
intended to be inclusive in a manner similar to the term "comprise"
as "comprise" is interpreted when employed as a transitional word
in a claim.
[0048] The Title, Background, Summary, Brief Description of the
Drawings and Abstract of the disclosure are hereby incorporated
into the disclosure and are provided as illustrative examples of
the disclosure, not as restrictive descriptions. It is submitted
with the understanding that they will not be used to limit the
scope or meaning of the claims. In addition, in the Detailed
Description, it can be seen that the description provides
illustrative examples and the various features are grouped together
in various embodiments for the purpose of streamlining the
disclosure. This method of disclosure is not to be interpreted as
reflecting an intention that the claimed subject matter requires
more features than are expressly recited in each claim. Rather, as
the following claims reflect, inventive subject matter lies in less
than all features of a single disclosed configuration or operation.
The following claims are hereby incorporated into the Detailed
Description, with each claim standing on its own as a separately
claimed subject matter.
[0049] The claims are not intended to be limited to the aspects
described herein, but are to be accorded the full scope consistent
with the language claims and to encompass all legal equivalents.
Notwithstanding, none of the claims are intended to embrace subject
matter that fails to satisfy the requirement of 35 U.S.C. .sctn.
101, 102, or 103 nor should they be interpreted in such a way.
* * * * *